Tissue anchor and anchoring system

ABSTRACT

An annuloplasty implant comprising an elongate member configured to be anchored to tissue of a heart, and to move between an elongate configuration and a shortened configuration and a tensioning member. The tensioning member can define a first segment and a second segment such that the first segment extends between a first tensioning-member end and a turn of the tensioning member, and the second segment extends between the turn and the second tensioning-member end. The tensioning member extends along the elongate member such that the elongate member can slide relative to the tensioning member and such that applying tension to the tensioning member causes the elongate member to move from the elongate configuration to the shortened configuration, which can cause the implant to reshape an annulus of a heart valve.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/680,742, filed Aug. 18, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/581,264, filed Dec. 23, 2014, now U.S. Pat. No.9,814,454, issued Nov. 14, 2017, which is a continuation of U.S. patentapplication Ser. No. 12/273,670, filed Nov. 19, 2008, now U.S. Pat. No.8,951,286, issued Feb. 10, 2015, which is a divisional of U.S. patentapplication Ser. No. 11/174,951, filed Jul. 5, 2005, now U.S. Pat. No.8,951,285, issued Feb. 10, 2015, the contents of each of which arehereby incorporated by reference in their entireties for all purposes.

TECHNICAL FIELD

The present invention generally relates to tissue anchors and, moreparticularly, anchors and methods of using such anchors to secure anelement or otherwise provide an anchor point to biological tissue and/orto secure at least two tissue portions together.

BACKGROUND

Many different surgical procedures require that an anchor be used toeither establish a strong point of connection for other securingelements or devices relative to a tissue location in a patient, and/orto secure two or more tissue layers (i.e., portions together. In thisregard, the term “anchor”, as used herein, is not to be limited to anyparticular type of tissue fastening or securement application but,rather, encompasses any hard and/or soft tissue-to-tissue securement,tissue-to-device securement, or any other tissue securement application.

One particular area that has received attention in recent years is thatof catheter-based surgical procedures. Various tissue anchors have beendeveloped for purposes of deployment and securement with catheter-basedtechnology. However, there are still limitations in current technology.For example, insertion size versus deployment size must be strictlycontrolled due to the need for catheter diameters to be maintainedrelatively small. Many catheter-based tissue anchor systems have veryspecialized uses and are not versatile for use in many different tissuefastening or securement operations.

There is generally a need for a simpler, more versatile tissue anchorwhich may be deployed and securely fastened to tissue in acatheter-based operation or a non-catheter-based operation.

SUMMARY

In one aspect, the invention provides a tissue anchor comprising agenerally flexible anchor member capable of being inserted throughtissue and moving between an elongate configuration and a shortenedconfiguration suitable for anchoring against at least one side of thetissue. The anchor member includes a proximal end portion, a distal endportion, and a compressible intermediate portion between the proximalend portion and the distal end portion. A tensioning member isoperatively connected to the anchor member such that the anchor membercan slide relative to the tensioning member. The tensioning member maybe pulled to cause the anchor member to move relative to the tensioningmember from the elongate configuration to the shortened configuration.In the shortened configuration, the compressible intermediate portion ofthe anchor member can compress or shorten and thereby adjust to thethickness of the tissue between the proximal and distal end portions.

In another aspect of the invention, a tissue anchor is providedcomprising a flat, generally flexible anchor member capable of movementbetween an elongate configuration suitable for deployment and ashortened configuration suitable for anchoring against tissue. Atensioning member is operatively connected to the anchor member suchthat the anchor member can slide relative to the tensioning member. Thetensioning member is capable of being pulled to cause the anchor memberto move relative to the tensioning member from the elongateconfiguration to the shortened configuration.

In a further aspect of the invention, a tissue anchor is providedcomprising a flat anchor member formed from a strip of fabric materialand capable of movement between an elongate configuration suitable fordeployment and a shortened configuration suitable for anchoring againsttissue. A tensioning member is operatively connected to the anchormember such that the anchor member can slide relative to the tensioningmember. The tensioning member is capable of being pulled to cause theanchor member to move relative to the tensioning member from theelongate configuration to the shortened configuration. A lock member isprovided for securing the anchor member in the shortened configuration.

In a further aspect of the invention, a tissue anchor is providedcomprising a flat, generally flexible anchor member capable of beinginserted through tissue and moving between an elongate configurationsuitable for deployment through a catheter and a shortened configurationsuitable for anchoring against the tissue. A tensioning member isoperatively connected to the anchor member such that the anchor membermay slide relative to the tensioning member. The tensioning member iscapable of being pulled to cause the anchor member to move relative tothe tensioning member from the elongate configuration to the shortenedconfiguration against the tissue.

In another aspect of the invention, a tissue anchor is providedcomprising a flat elongate strip formed from a generally flexiblematerial and having proximal and distal end portions. A tensioningmember having first and second ends is operatively connected to theelongate strip such that pulling on the first end of the tensioningmember causes the proximal and distal end portions of the elongate stripto move toward each other to a shortened configuration suitable foranchoring against the tissue.

In certain aspects, the anchor member is advantageously formed as aflat, generally flexible strip of material, while in other aspects itneed not be a flat strip but may have other shapes, such as tubular,that may or may not be capable of assuming a flat shape. Variousoptional features may be incorporated into any or all of the variousembodiments of the tissue anchor. For example, the tissue anchor may beformed from a material selected from at least one of: natural fibers,synthetic fibers, polymers, and metals. Such materials may be absorbableor nonabsorbable, and may be radiopaque or at least partiallyradiopaque. The tensioning member may further comprise a suture, or anyother suitable flexible, semi-rigid or rigid tensioning member. Thetensioning member may include a stop member engaged with the anchormember, such as a knot in the tensioning member, or a separate stopmember (e.g., a crimp) engageable with the anchor member. The tensioningmember may, for example, extend through the anchor member at multiplelocations between the proximal end portion and the distal end portion.Such coupling of the tensioning member and the anchor member may beconfigured in many different manners depending, for example, on thedesired configuration of the anchor member upon pulling the tensioningmember and moving the anchor member into the shortened configuration. Inone embodiment, at least one fold is formed upon pulling the tensioningmember. Multiple folds may be formed in a generally zig-zag or accordionfashion. A lock member may be provided and engageable with thetensioning member to retain the anchor member in the shortenedconfiguration. The tissue anchor may include at least one radiopaquemarker on one or both of the anchor member and the tensioning member.For example, a first radiopaque marker may be located near the proximalend portion when the anchor member is in the shortened configuration anda second radiopaque marker may be located near the distal end portionwhen the anchor member is in the shortened configuration. The distal endportion of the anchor member may include a relatively more rigid tip ascompared to the anchor member and having a reduced width as compared toan adjacent portion of the anchor member. The anchor member itself maybe designed in any of numerous manners, including designs that have auniform width along the length thereof, and designs that have a varyingwidth along the length. Other features may be incorporated such as edgeportions that are slightly more rigid than a central area of the anchormember. Entire sections of the anchor member may be relatively rigid ascompared to fold line portions thereof while still resulting in agenerally flexible anchor member. As necessary, hinge portions, such asliving hinges, may be designed into the anchor member to allow forfolding or other shortening action of the anchor member. While atensioning member is specifically disclosed herein for activationpurposes (that is, activating the anchor member from the elongateconfiguration to the shortened configuration), the invention in variouscombinations may utilize other types of activation, such as compressiveactivation.

Each of the embodiments of the tissue anchor may be part of acatheter-based anchoring system having a delivery catheter and asuitable deploying device associated with the delivery catheter andoperable to extend the anchor member from the delivery catheter. Thedeploying device may further comprise a deploying catheter at leastpartially containing the anchor member and at least partially containedwithin the delivery catheter.

The invention further provides for various methods of anchoring tissueas generally described herein. For example, in one aspect a method ofanchoring tissue is provided comprising inserting a generally flexibleelongate anchor member through the tissue, and pulling a first end of atensioning member coupled for sliding movement relative to the firstanchor member to draw the proximal and distal end portions toward eachother and to compress the intermediate portion into the shortenedconfiguration with at least one of the proximal and distal end portionsengaged against the tissue.

In another aspect of the invention, a method of tissue anchoring isprovided comprising inserting the generally flexible flat elongate striphaving proximal and distal end portions through the tissue, and pullinga first end of a tensioning member operatively connected to the strip todraw the proximal and distal end portions of the strip toward each otherinto the shortened configuration engaged against the tissue.

In another aspect, a method of tissue anchoring is provided comprisinginserting the generally flexible flat elongate strip having proximal anddistal end portions through the tissue, and pulling a first end of atensioning member operatively connected to the strip to configure atleast a portion of the strip into a shortened configuration engagedagainst the tissue.

In each of the embodiments engagement of the anchor member against thetissue may be engagement against opposite sides of at least one tissuelayer, or engagement against only one side of at least one tissue layer.

Additional features and advantages of the invention will become readilyapparent to those of ordinary skill in the art upon review of thefollowing detailed description of the illustrative embodiments taken inconjunction with the accompanying illustrative figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a tissue anchor constructed inaccordance with a first embodiment of the invention.

FIG. 2A is a side view of the tissue anchor shown in FIG. 1, with thetissue anchor deployed through a layer of tissue.

FIG. 2B is a side view similar to FIG. 2A, but illustrating the distalportion of the tissue anchor being moved toward the layer of tissue.

FIG. 2C is a side view similar to FIG. 2B, but showing the distalportion fully compressed and engaged against the layer of tissue.

FIG. 2D is a side view similar to FIG. 2C but illustrating the proximalportion of the tissue anchor being moved toward the layer of tissue.

FIG. 2E illustrates the proximal and distal portions of the tissueanchor fully compressed against opposite sides of the layer of tissue.

FIG. 2F is an enlarged cross sectional view illustrating the fullydeployed and fastened anchor with a layer of tissue between proximal anddistal anchor portions.

FIG. 3 is a side cross sectional view similar to FIG. 2F, butillustrating the fastening of two layers of tissue between the proximaland distal anchor portions.

FIGS. 4A-4F are perspective views illustrating successive steps in anannuloplasty procedure on the mitral valve of a patient utilizing tissueanchors of the first embodiment.

FIGS. 5A-5E are perspective views illustrating a mitral valveannuloplasty procedure utilizing tissue anchors constructed according toa second embodiment of the invention.

FIG. 6 is a side elevational view illustrating the tissue anchorconstructed in accordance with the second embodiment.

FIG. 7 is a front view of the elongate strip portion of the anchor.

FIG. 7A is a front elevational view similar to FIG. 7, but illustratingone embodiment of radiopaque markers used on the elongate strip.

FIG. 7B is a front elevational view of an alternative anchor striphaving a varying width along its length.

FIG. 7C is a side elevational view of another alternative anchor striputilizing more rigid fold sections separated by living hinges.

FIGS. 8A-8D are respective side views illustrating a sequence of stepsused for securing the tissue anchor of the second embodiment to a layerof tissue.

FIG. 8E is a view similar to FIG. 8D, but illustrating an alternativetip and tensioning member arrangement.

FIGS. 9A-9C are respective side elevational views illustrating anannuloplasty procedure in which two tissue anchors of the secondembodiment are daisy-chained together with a single tensioning member toplicate the tissue between the anchors in a more integrated procedure.

FIGS. 10A and 10B are respective side elevational views illustrating thetissue anchor of the second embodiment used to provide an anchor orsecurement location on only one side of a tissue layer.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring first to FIG. 1, a tissue anchor 10 constructed in accordancewith a first embodiment of the invention generally includes a tensioningmember 12, such as a suture, extending through spaced apart points alonga flat elongate strip 14 of flexible material, such as a surgical gradefabric. It will be appreciated that the tensioning member 12 may takeother forms other than suture material, such as cable or any other smalldiameter member having a high enough tensile strength for the intendedanchoring use. The elongate strip 14 may also take various forms such aswoven or nonwoven fabrics, polymers, metals or other suitable materialsor combinations of materials. One or more separate pledgets or othersecurement members (not shown) may be used in conjunction with theelongate strip 14 for added securement and/or concealing the elongatestrip 14 and, for example, thereby inhibiting blood clotting within oradjacent to the folds that will be formed in the strip 14.

A woven or nonwoven material may contain additional materials, such asthreads, beads or other elements that cause at least portions of thestrip 14 to be radiopaque. Currently, a surgical grade fabricconstructed from polyester, such as Dacron®, is contemplated for use inconstructing the strip 14. One of many possible alternative materialsfor use in constructing strip 14 is polytetrafluoroethylene (PTFE).Tissue anchor 10 may be partly or wholly formed from materials that areabsorbed into the patient's tissue over time, depending on the intendeduse. The edges and/or other portions of the strip 14 may be suitablymodified to prevent fraying, such as by being coated with a materialthat locks the fibers in place, or otherwise modified in a manner thatlocks the fibers at least at the edges of the strip 14 in place.

The suture 12 may extend from a proximal end portion 14 a of the fabricstrip 14 to a distal end portion 14 b and then loop back through spacedapart points of the fabric strip 14 to the proximal end portion 14 awhere a knot 16 or other stop member is located for reasons to bedescribed below. As will become apparent, the suture 12 extends throughspaced apart locations along the elongate strip 14 such that tensioningof the suture 12 or other tensioning member will cause the elongatestrip 14 to form folded portions 14 c when the tensioning member 12 isplaced under tension or pulled. Thus, the elongate strip 14 is activatedin this manner between essentially an elongate deployment orientation orconfiguration, such as shown in FIG. 1, and a shortened configuration,such as a folded or otherwise shortened configuration having an expandedwidth in at least one dimension as compared to the elongate deploymentconfiguration. It will be appreciated that the deployment orientationmay take on various forms due to the flexible nature of the strip 14,especially when using a highly flexible fabric or other material. Forexample, a fabric material or other similarly flexible materials may befolded or otherwise deformed for carrying purposes within a catheterand/or during deployment to a tissue site and then suitably activated atthe tissue site.

More specifically referring to FIGS. 2A-2E, the elongate strip 14 andattached suture 12 are initially inserted through at least one tissuelayer 20 as generally shown in FIG. 2A. One end or portion 12 a of thesuture 12 is then pulled and thereby placed under tension. It will beappreciated that, for catheter-based procedures, suture portion 12 a mayextend to a location outside the patient's body for pulling ortensioning, or it may be grasped by a suitable mechanism within thecatheter and pulled or tensioned. Pulling suture portion 12 a mayinitially draw the distal portion 14 b of the elongate strip 14 towardthe layer of tissue 20 as shown in FIG. 2B. Once the distal portion 14 bis compressed against the layer of tissue 20, the proximal portion 14 abegins to be drawn and compressed against a proximal side of the tissue20 as shown in FIGS. 2C-2E. This occurs because end 12 a of the suture12 is being pulled downwardly (as viewed for purposes of discussion inFIGS. 2C-2E) and, since the suture 12 is looped in a reverse directionthrough distal end portion 14 b of the elongate strip 14, the knot 16 atthe end of the suture 12 moves upwardly and brings the proximal portion14 a of the elongate strip 14 with it. In this manner, the proximalportion 14 a of the elongate strip 14 is being folded and drawn alongthe suture 12 toward the layer of tissue 20 and then firmly compressedagainst the proximal side of the layer of tissue 20 as shown in FIG. 2E.As further shown in FIG. 2F, a suitable locker element, such as a crimpmember 22, a knot or other element may be used to maintain the suture 12and elongate strip 14 in the positions shown in FIG. 2F securelyanchoring the proximal and distal portions 14 a, 14 b of the elongatestrip 14 folded against opposite sides of the tissue 20.

As further shown in FIG. 3, the same general procedure may be used tosecure two distinct tissue layers 30, 32 together by initialingextending the elongate strip 14 and tensioning member 12 through atleast two layers of tissue 30, 32. In this manner, for example, twolayers of tissue 30, 32 may be securely fastened together. This may, forexample, involve two entirely different layers and even types of tissueor the same layer of tissue which has been folded over to effectivelyform two layers (i.e., portions) of tissue.

FIGS. 4A-4E schematically illustrate an annuloplasty procedure performedon a mitral valve 40 of a heart 42 utilizing tissue anchors 10 asdescribed above in regard to the first embodiment. Performance of theannuloplasty procedure may have many variations, but is generallyillustrated by the placement of at least two tissue anchors 10 andsecurement of the two anchors 10 together, such as with one or moretensioning members 12 therebetween. For an additional illustrativedescription of catheter-based annuloplasty procedures that may utilizeany of the tissue anchors within the scope of the present invention,reference may be made to U.S. patent application Ser. No. 10/948,922,filed on Sep. 24, 2004, assigned to the assignee of the presentinvention, and the disclosure of which is hereby entirely incorporatedby reference herein.

As illustrated in FIG. 4A, a first tissue anchor 10 is deployed througha catheter device 50 which may, for example, have an inner tubularmember 52 or deploying catheter received within an outer tubular member54 or delivery catheter. The tissue anchor 10 and tensioning member 12are carried within the inner tubular member 52 and are deployed from adistal end 52 a thereof. To ensure that proper force is applied topenetrate the tissue, tissue anchor 10 may be deployed or extended afterthe inner tubular member 52 has been inserted through tissue at theannulus 40 a of the mitral valve 40. This is best illustrated in FIG.4B. The inner tubular member 52 is withdrawn from the annulus tissue 40a either before, during or after activation of the distal end portion 14b of the elongate strip 14. As previously described, activating (e.g.,compression, folding or otherwise shortening) the elongate strip 14 bypulling the suture 12 causes the distal end portion 14 b and thenproximal end portion 14 a to be securely compressed and folded againstopposite sides of the annulus tissue 40 a. This procedure is repeated atleast one additional time to securely fasten an additional tissue anchor10 at a location spaced from the initial location. For example, theinitial location may be at location P2 of the mitral valve annulus 40while the second location may be spaced on either side of location P2.Catheter device 50 may be inserted into the location of annulus 40 a invarious manners, but is shown being inserted downwardly through theaortic valve 53 into the left ventricle 55, and curving upward towardthe mitral valve annulus 40 a.

In the illustrative example shown in FIG. 4E, three tissue anchors 10have been deployed and securely fastened to the annulus tissue 40 a. Asshown in FIG. 4F a suture locker 56 may then be deployed and used tomaintain relative position and, therefore, tension between each of threerespective tensioning members or sutures 12 associated with the threetissue anchors 10 after the tissue anchors 10 have been pulled closer toeach other thereby plicating the tissue 40 a between the anchors 10.This essentially shortens the valve annulus 40 a and pulls the posteriorleaflet 60 toward the anterior leaflet 62 to prevent leakage through thevalve 40, i.e., to achieve better coaptation of the posterior andanterior leaflets 60, 62 during systole.

FIGS. 5A-5E illustrate a similar annuloplasty procedure on a mitralvalve 40 utilizing a second embodiment of a tissue anchor 70 and amodified method of deployment and activation. In general, thedifferences between anchor 70 and anchor 10 will be described below withthe understanding that all other attributes, options and featuresassociated with anchor 70 may be as described above in connection withanchor 10. As shown in FIG. 5A, in this embodiment a tensioning member72 is again used to activate a flexible, elongate flat strip 74 havingproximal and distal end portions 74 a, 74 b. Strip 74 includes a tip 76that is formed or otherwise secured on the distal end portion 74 b. Thetensioning member 72 and the tip 76 are arranged such that thetensioning member 72 slides relative to the tip 76. More particularly,the tensioning member 72 can be threaded through the tip 76. Tip 76 ismade to be relatively rigid as compared to other flexible portions ofstrip 74 and of smaller diameter than the width of strip 74. Therefore,tip 76 helps to penetrate the annulus tissue 40 a as the inner tubularmember 52 and the elongate strip 74 are extended through the tissue 40a. A wire 73 may be used to push the tip 76 out of the tubular member 52at the desired time. The tip 76 may protrude slightly from the innertubular member 52 as the tissue 40 a is penetrated to assist withpiercing the tissue 40 a. The tip 76 may also assist with forcing distalportion or half 74 b of strip 74 into a folded or otherwise shortenedconfiguration. To help prevent the distal portion 74 b of the elongatestrip from pulling back through the tissue 40 a as the inner tubularmember 52 is withdrawn from the annulus tissue 40 a, the free end of thetensioning member 72 is pulled while the inner tubular member 52 isstill penetrated through the tissue 40 a and into the left atrium 80from the left ventricle 55. This forms the distal portion 74 b into afolded or otherwise shortened configuration as shown in FIG. 5B. Theinner tubular member 52 may then be withdrawn without also withdrawingthe elongate flexible strip 74 with it, as shown in FIG. 5C. Theproximal portion 74 a of the elongate strip 74 is then deployed bypulling the inner tubular member 52 further in a proximal direction, andthereby exposing the full length of strip 74. The tensioning member 72is pulled or tensioned so as to draw and compress the proximal portion74 a of the elongate strip 74 into a folded, shortened condition againstan underside of the annulus tissue 40 a as shown in FIG. 5D. As with thepreviously described annuloplasty procedure using the first embodimentof the tissue anchor 10, this is repeated as many times as necessary tocreate the necessary number of tissue plications. FIG. 5E illustratesthis by way of an exemplary view of three successive tissue anchorsecurement locations with tissue anchors 70 that may be drawn togetherand locked in place to achieve and retain the plications as described inconnection with FIG. 4F. Such plications reduce or close the gap betweenthe posterior and anterior leaflets 60, 62. during systole

FIG. 6 is a side elevational view of the tissue anchor 70 as shown anddescribed with respect to the annuloplasty procedure of FIGS. 5A-5E.This embodiment differs from the first embodiment in a number ofdifferent manners, in addition to the use of a distal tip 76 for tissuepenetration purposes. For example, the elongate strip 74 is somewhatshorter than the elongate strip 14 utilized in the first embodiment. Forexample, the strip 74 may be about 40 mm long by about 3 mm wide. Ofcourse, any other desired dimensions and shapes may be used depending onapplication needs. This may be desirable to achieve a lower profiledeployed and fastened configuration with fewer folds that may lead tomore versatile applications, lower incidents of blood clotting, easieruse, etc. In addition, respective proximal and distal radiopaque bands90, 92 are secured to the suture 72 at the proximal end portion of thestrip 74 and to either the interior or exterior of the distal tip 76.Under a fluoroscope, these bands or other markers 90, 92 will indicateto the surgeon that the anchor 70 has been deployed, activated and fullycompressed and/or fastened as necessary during the procedure. The tip 76itself may alternatively be formed from a radiopaque material. In thissecond embodiment, the knot 94 formed in the suture 72 or othertensioning member is a slip knot through which another portion of thesuture 72 slides during activation of the tissue anchor 70. It will beappreciated that this slip knot 94 may be replaced by another elementwhich serves essentially the same purpose but takes the form, forexample, of a small tubular element or other feature similar in functionto a slip knot.

As further shown in FIGS. 6 and 7, the tensioning member or suture 72can advantageously extend through respective fold portions 74 c of theelongate strip 74 in essentially an hourglass configuration.Specifically, adjacent portions of the suture 72 located near theproximal and distal end portions 74 a, 74 b of the strip 74 are spacedfarther apart than the adjacent portions of the suture 72 in the middleof the strip 74. As further shown in FIG. 7A, radiopaque markers, suchas distinct areas of dots 95, may be used for enabling the surgeon tovisualize the folds of the elongate strip 74 during deployment andsecurement of the elongate strip 74. These dots or other radiopaquemarkers may be printed on the strip 74. For example, dots 95 or othermarkers may be formed with a platinum powder base ink or other suitablematerial that is radiopaque and biologically compatible. This radiopaquematerial may also add stiffness to the fold sections 74 c therebyhelping to maintain the fold sections 74 c flat and increasing retentionforce on the tissue. Meanwhile, the fold lines 74 d between foldsections 74 c can remain highly flexible to create tight radius foldlines. As further shown in FIG. 7, each of the holes 96 that thetensioning member or suture 72 is received through may be marked bycircles 98 surrounding each hole 96 or other markers for visualizingpurposes during assembly of the tensioning member or suture 72 with theelongate strip 74. Optionally, holes 96 may be eliminated and the suture72 may be threaded with a needle through the strip 74. One could also,for example, choose different sets of holes 96 along strip 74 forreceiving the tensioning member or suture 72 thereby changing the widthof the folds and/or number of folds and/or shape of the folds dependingon the application needs or desires of the surgeon. The tensioningmember or suture 72 may be threaded or otherwise attached along thestrip 74 in any number of manners including, for example, x-patterns orother crossing patterns, zig-zag patterns, etc. that may alter thefolded or otherwise shortened or compressed footprint of the anchor intovarious beneficial shapes, such as flower shapes, circular shapes orother rounded shapes, ball shapes or other configurations. Modificationsof the manner in which the tensioning member or suture 72 is threaded orotherwise attached along the length of strip 74 may result in higher orlower tensioning force being required to compress the anchor and/orhigher or lower friction holding force that may help maintain the anchorin the compressed or shortened configuration. The width of the elongatestrip 74′ may be varied along its length, such as by tapering, stepping,or forming an hourglass shape or shapes along the length of the strip14. For example, as illustrated in FIG. 7B, having proximal and distalend portions 75, 77 of wider dimension than an intermediate or middleportion or portions 79 along the length of strip 74′ will allow thesewider portions 75, 77 may cover over the more intermediate foldedportions 79 and prevent unnecessary contact with adjacent tissue duringuse. It will be appreciated that like reference numerals are used hereinto refer to like elements in all embodiments and reference numerals withprime marks (′) or double prime marks (″) refer to like elements thathave been modified in a manner as described herein or otherwise shown inthe associated figure. Strip 74 may have variable stiffness including,for example, a relatively rigid perimeter or relatively rigid edges 74e, 74 f (FIG. 7) or intermittent relatively rigid sections 74 c″separated by flexible sections such as living hinges 74 d″ (FIG. 7C)that may aid in folding and securing the elongate strip 74″ into afolded condition.

FIGS. 8A-8D illustrate a series of steps for deploying and securelyfastening the tissue anchor 70 of the second embodiment to a layer oftissue 100. Generally, as shown in FIG. 8A, the combination of theelongate strip 74 and tensioning member or suture 72 is deployed throughthe layer of tissue 100. One end or portion 72 a of the suture 72 thatextends through the slip knot 94 is then pulled. This causes the distalportion 74 b of the elongate strip 74 to fold and compress against thedistal side of the tissue layer 100. As shown in FIG. 8B, furtherpulling of the tensioning member 72 causes the slip knot 94 to rideupwardly or distally along the suture 72 and against a proximal portion74 a of the elongate strip 74 thereby folding and compressing theproximal portion 74 a against the proximal side of the tissue layer 100as shown in FIG. 8C. As shown in FIG. 8D, a suitable crimp or lockingelement 102 may be used to securely lock the slip knot 94 in placerelative to the suture or tensioning member segment which extendstherethrough. This will lock the entire anchor 70 in place with therespective proximal and distal folded strip portions 74 a, 74 b securelyretaining the tissue layer or layers 100 therebetween. FIG. 8D shows thetip 76 acting as a retainer on top of the distal end portion 74 b toassist in holding the distal end portion 74 b in place. FIG. 8E shows analternative in which the tensioning member is threaded through at leastone hole 76 a more centrally located in the tip. Yet another alternativewould be to thread the tensioning member through two centrally locatedholes instead of through the proximal end of the tip 76 and onecentrally located hole 76 a as shown in FIG. 8E. These alternativesallow the tip 76 to act more like a “T”-bar with forces acting in a moreperpendicular or normal manner relative to the distal end portion 74 bof the strip 74.

FIGS. 9A-9C illustrate another alternative embodiment of a plicationprocedure, for example, for use during annuloplasty on a mitral valveannulus 40 a. In this regard, a single tensioning member, such as asuture 103 or other member may be used to deploy, fasten and drawtogether at least two separate tissue anchors 110. As shown in FIG. 9A,first and second tissue anchors 110 may be respectively deployed atspaced apart locations along the mitral valve annulus 40 a. Each tissueanchor 110 includes an elongate strip 114 of flexible material, such asfabric or other material as described above, as well as a single suture103 or tensioning member extending through each of the elongate strips114. Upon deployment of the two tissue anchors 110 through the tissuelayer 40 at spaced apart locations, the free end of the suture 103 ortensioning member is pulled thereby securely fastening the first tissueanchor 110 as shown in FIGS. 9A and 9B and subsequently securelyfastening the second tissue anchor 110 to the annulus tissue 40 a. Uponfurther pulling or tensioning of the suture 103, the tissue anchors 110will be drawn together to plicate the tissue 40 therebetween as shown inFIG. 9C. A crimp or other locker member 116 may then be used to lock inthe desired amount of plication by crimping onto the free end of thesuture 103 adjacent to the slip knot 94 of the first tissue anchor 110as shown in FIG. 9C. The free end of the suture 103 may then be cut toeliminate or reduce the length of the suture tail.

FIGS. 10A and 10B illustrate a tissue anchor 70 of the secondembodiment, for example, being used to provide an anchor or securementlocation on only one side of a tissue layer 120. In this regard, thetissue anchor 70 may be extended entirely through the tissue layer(s)120. The free end of the suture or tensioning member 72 is then pulledproximally to compress and fold the elongate strip 74 against the distalside of the tissue layer 120 as shown in FIG. 10B. It will beappreciated that activation of strip 74 occurs similarly to the otherdescribed embodiments, except that the activated portion (that is, thefolded or otherwise shortened portion) is located entirely on one sideof the tissue layer 120. As illustrated, the intermediate or middleportion between the proximal and distal end portions of the anchormember shortens to adjust to the amount of tissue contained therebetween(if any) or shortens during the compression process on only one side ofthe tissue.

While the present invention has been illustrated by a description ofvarious illustrative embodiments and while these embodiments have beendescribed in some detail, it is not the intention of the Applicant torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. The various features of the invention may beused alone or in numerous combinations depending on the needs andpreferences of the user.

What is claimed is:
 1. An annuloplasty implant comprising: an elongatemember configured to be anchored to tissue of a heart, and to movebetween an elongate configuration and a shortened configuration, theelongate member having a first end portion, a second end portion, and acompressible intermediate portion between the first end portion and thesecond end portion; and a tensioning member: having a firsttensioning-member end and a second tensioning-member end, defining afirst segment and a second segment such that (i) the first segmentextends between the first tensioning-member end and a turn of thetensioning member, (ii) the second segment extends between the turn andthe second tensioning-member end, and extending along the elongatemember between the first end portion and the second end portion, suchthat the elongate member can slide relative to the tensioning member,and such that applying tension to the tensioning member causes theelongate member to move from the elongate configuration to the shortenedconfiguration by the tensioning member pulling both the first endportion and the second end portion toward the intermediate portion andcompressing the intermediate portion, which can cause the implant toreshape an annulus of a heart valve.
 2. The implant according to claim1, wherein the elongate member is formed from a material selected fromat least one of: natural fibers, synthetic fibers, polymers, and metals.3. The implant according to claim 1, wherein the tensioning memberfurther comprises a suture.
 4. The implant according to claim 1, whereinthe tensioning member includes a stop member engageable with theelongate member.
 5. The implant according to claim 4, wherein the stopmember further comprises a knot in the tensioning member.
 6. The implantaccording to claim 1, wherein the tensioning member extends through theelongate member at multiple locations between the first end portion andthe second end portion.
 7. The implant according to claim 1, wherein theelongate member and the tensioning member are configured such that theelongate member forms at least one fold upon pulling the firsttensioning-member end.
 8. The implant according to claim 1, furthercomprising a lock member engageable with the tensioning member to retainthe elongate member in the shortened configuration.
 9. The implantaccording to claim 1, further comprising at least one radiopaque markeron at least one of the elongate member and the tensioning member. 10.The implant according to claim 1, further comprising a first radiopaquemarker located proximate the first end portion of the elongate member isin the shortened configuration and a second radiopaque marker locatedproximate the second end portion when the elongate member is in theshortened configuration.
 11. The implant according to claim 1, whereinthe implant comprises a tip at the second end portion, the tip beingnarrower and more rigid than the elongate member.
 12. The implantaccording to claim 11, wherein the tip acts as a compressive forceapplying member against the second end portion of the elongate memberwhen the elongate member is in the shortened configuration.
 13. Theimplant according to claim 1, wherein the elongate member varies inwidth along its length when in the elongate configuration.
 14. Theimplant according to claim 1, wherein the elongate member includes anedge portion that is more rigid than a central area of the elongatemember.
 15. The implant according to claim 1, wherein at least the firsttensioning-member end is disposed at the first end portion of theelongate member.
 16. A system including the implant according to claim 1and a catheter device, wherein the implant is configured to betransluminally delivered to the heart valve through the catheter device,with the second end portion distal to the first end portion, such thatdeployment of the implant from the catheter device exposes the secondend portion prior to the first end portion.
 17. The implant according toclaim 1, further comprising a catheter device configured to facilitatesecuring of the second end portion to the tissue, and to facilitatesecuring of the first end portion to the tissue subsequently to thesecuring of the second end portion to the tissue.
 18. A system,comprising: an annuloplasty implant that comprises: an elongate memberconfigured to be anchored to the tissue, and to move between an elongateconfiguration and a shortened configuration, the elongate member havinga first end portion, a second end portion, and a compressibleintermediate portion between the first end portion and the second endportion; and a tensioning member having a first tensioning-member endand a second tensioning-member end, defining a first segment and asecond segment such that (i) the first segment extends between the firsttensioning-member end and a turn of the tensioning member, and (ii) thesecond segment extends between the turn and the second tensioning-memberend, wherein the tensioning member extends along the elongate memberbetween the first end portion and the second end portion and is arrangedsuch that the elongate member can slide relative to the tensioningmember; and a catheter device configured to facilitate securing of thesecond end portion to the tissue, and to facilitate securing of thefirst end portion to the tissue subsequently to the securing of thesecond end portion to the tissue; wherein the tensioning member iscoupled to the elongate member is such that applying tension to thetensioning member causes the elongate member to move from the elongateconfiguration to the shortened configuration by the tensioning member(i) pulling both the first end portion and the second end portion towardthe intermediate portion, and (ii) compressing the intermediate portion,which can cause the implant to reshape an annulus of a heart valve.